This study was approved on 04/30/2012 and is currently enrolling patients. Enrollment is currently 44% to completion. No safety and tolerability events have occurred to affect progression of the study. The study remains blinded, and therefore no additional detail or analysis will be available until after the completion of the dose escalation. Details of the study are posted at ClinicalTrial.gov http://clinicaltrials.gov/ct2/show/NCT01597401 and at the NIH Clinical Center web site: http://clinicalstudies.info.nih.gov/cgi/wais/bold032001.pl?A_12-H-0127.htmlaes-103